The States of Pain Regulation

Dr. Lewis is well known to the National Pain Report. She will write a series of articles in September that address the big issues facing chronic pain and chronic illness patients. Here is her first installment.

Who Are the People We Are Concerned About?

Marlene is a single 42 year old woman who resides in public housing in southern Indiana. She has a history of substance abuse but has been free of its’ effects for four years. She also has a blood clotting disorder that caused a major abdominal bleed, requiring her to present to her local emergency room for pain related symptoms. Her history of substance abuse resulted in ER personnel turning her away from the department after she was labeled as drug seeking. Moreover, the abdominal bleed resulted in blood clots that formed in her legs, with amputation of both lower limbs the result. After Marlene’s amputations, she was discharged to her home with a 7 day prescription for opiates which her insurer, Humana, refused to authorize because opiates are no longer covered on her dual Medicare, Medicaid policy. The recommended substitutions were contraindicated for her rare blood clotting disorder. Marlene was able to borrow $400.00 from her family members to obtain 7 days of minimum relief. Her next appointment is on September 26 where she will be evaluated for possible changes to the medication that controls her blood clotting factors.

David, 38, is a young father of four, a five year survivor of the fungal meningitis outbreak. He still suffers from the effects of his exposure to contaminated epidural injections with headaches, vision disturbances, tinnitus, adhesive arachnoiditis and fibromyalgia. The state that he lives in has battled opiate addiction aggressively causing most physicians to drop patients who require complex coordinated health supports. His neurosurgeon recommended and installed a pain pump which resulted in 3 unsuccessful surgeries for pump repositioning and a blood patch. The CSF leak remains. The daily morphine equivalent dose has been reduced to 40 MME, insufficient to reduce his pain levels. David is denied oral medications for breakthrough pain support. He spends 20 of 24 hours per day in a reclining position in a dark room. Parenting is difficult. Suicidal ideation is real.

September is Pain Awareness Month

As we advance into the month of September, I will be taking a close look at the systems issues that surround current pain policy across the United States. Our interactions with the care system are built on a scaffold of law, regulation, policy, professional practices, insurance regulations, guidelines, and personal resources. This scaffold is destabilizing across the system as new guidelines and reactive public responses to the increasing numbers of opioid associated overdoses seizes the public imagination. Some might say it is collapsing under its own weight. In any case it is important that we understand how consumers and practitioners are affected within the structures that currently ration our resources. First, to open this discussion, let’s begin with laws, regulation, and policy. Second, I will address how these are implemented by federal and state organizational structures. Third, I will address how these structures influence the care that consumers are able to access.

Terri Lewis, PhD

Even prior to the publication of both the CDC’s and VA’s Guidelines for Treatment of Chronic Pain, a number of states were advancing opioid prescribing legislation designed to limit, or reduce the number of prescriptions written for controlled narcotics. The promulgation of such legislation became a method for assuring that state departments of health programs received their full allotment of federal health dollars much in the same way that highway dollars are distributed based on the passage of seat belt, car seat, and driving under the influence legislation.

Federal laws that affect persons impacted by pain are largely regulated by the departments of Justice (Drug Enforcement Administration), and Health and Human Services (Food and Drug Administration, Centers for Disease Control, SAMHSA, NIDA, and National Institute of Health). These subdivisions handle various justice and public health functions in coordination with the states. Tracking of federal legislation can be found here:

The prohibition against opiates has a long history that continues to exert a strong social and cultural influence even today. The Harrison Act (1914) required sellers of opiates and cocaine to get a license, which set a legal precedent that any prescription for a narcotic given by a physician or pharmacist – even in the course of medical treatment for addiction – constituted conspiracy to violate the Harrison Act. The Supreme Court ruled in Doremus (1919) that the Harrison Act was constitutional and in Webb that physicians could not prescribe narcotics solely for maintenance. In Jin Fuey Moy v. United States, the court upheld that it was a violation of the Harrison Act even if a physician provided prescription of a narcotic for an addict, and thus subject to criminal prosecution.

The Harrison Act promulgated the initial federal governmental structures and cultural beliefs that continue to exert an influence on the government’s regulation of drug policy which is enforced at the (intra)state level, except where it affects interstate activities – pharmacy sales and commerce, illegal trafficking, and federal justice system activities.

Prescribing and pharmaceutical actions are regulated by each state through Departments of Health, acting through their authorities to regulate the practice of medicine within their states. Each state has something akin to a Board of Medicine, a Board of Pharmacy, a Board of Dentistry, and other licensing entities. Some states separate these functions, and sometimes a single entity regulates all licensing activities in the state. Functions are prescribed by a system of state laws and regulations. The design of policy may be influenced by professional practice groups.

Insurance regulation acts in much the same way. Each state has a regulating insurance entity that looks to federal policy to consolidate laws across systems and manage regulations promulgated by the states. State resources vary, taxation structures vary, and cultural influences have an effect on priorities as demonstrated by laws that are engendered by state legislatures.

From state to state, these differences create wide variation in the design of laws, regulations, and policies that affect health care. The federal government allows for this under the concept of state’s rights, requiring that states meet minimum, not maximum requirements. This results in a patchwork of regulation and policy that fosters very different results across states, making it difficult for us to compare efforts or interpret the effectiveness of regulatory activity at either the state or the federal level.

These differences make us vulnerable to a truncated interpretation of results that tend to be explained based on a standardized or average effect on the population as a whole. In turn, these averages are applied to individual subgroups as a standard for comparison – this leads to very large errors of interpretation and meaning due to the differences that underlie the standardized data. This ‘best fit’ approach is often adopted by individual states in their approach to legislation, and design, and regulation of policies. It is quite evident in our national approach to pain policy legislation.

Standards

With their permission, I have changed the names of Marlene and David to protect their identities, but their experiences are quite real. They both experience very real intractable pain that will require complex care and pain support for the rest of their lives. Both have run into problems with the way their care protocol is being implemented and addressed within their state and with state resources. Why this is occurring is a matter of some concern and should cause us to question how this is possible in the current system of care. So let’s examine the system and look closely at the factors that influence their respective experiences.

The Federation of State Medical Boards has developed a model pain policy with recommended definitions and features to guide physicians who practice and state regulatory functions. Certainly states are not bound to adopt these recommendations but the majority of states have adopted policies that have incorporated the following definitions and criteria into their model language (sic) –

Definitions.

Acute Pain—Acute pain is the normal, predicted physiological response to a noxious chemical, thermal or mechanical stimulus and typically is associated with invasive procedures, trauma and disease. It is generally time-limited.

Addiction—Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and are not the same as addiction.

Chronic Pain—Chronic pain is a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.

Pain—An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

Physical Dependence—Physical dependence is a state of adaptation that is manifested by drug class specific

signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence, by itself, does not equate with addiction.

Pseudo addiction—The iatrogenic syndrome resulting from the misinterpretation of relief seeking behaviors as though they are drug-seeking behaviors that are commonly seen with addiction. The relief seeking behaviors resolve upon institution of effective analgesic therapy.

Substance Abuse—Substance abuse is the use of any substance(s) for non-therapeutic purposes or use of medication for purposes other than those for which it is prescribed.

Tolerance—Tolerance is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.

Evaluation of the Patient. A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient or with the patient’s surrogate or guardian if the patient is without medical decision-making capacity. The patient should receive prescriptions from one physician and one pharmacy whenever possible. If the patient is at high risk for medication abuse or has a history of substance abuse, the physician should consider the use of a written agreement between physician and patient outlining patient responsibilities, including o urine/serum medication levels screening when requested; number and frequency of all prescription refills; and reasons for which drug therapy may be discontinued (e.g., violation of agreement).

Periodic Review. The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician’s evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient’s decreased pain, increased level of function, or improved quality of life. Objective evidence of improved or diminished function should be monitored and information from family members or other caregivers should be considered in determining the patient’s response to treatment. If the patient’s progress is unsatisfactory, the physician should assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for medication misuse, abuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultation with or referral to an expert in the management of such patients.

Medical Records. The physician should keep accurate and complete records to include

the medical history and physical examination, 2) diagnostic, therapeutic and laboratory results, 3) evaluations and consultations, 4) treatment objectives, 5) discussion of risks and benefits, 6) informed consent, 7) treatments, 8) medications (including date, type, dosage and quantity prescribed), 9) instructions, and agreements and 10) periodic reviews. Records should remain current and be maintained in an accessible manner and readily available for review.

Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations.

The specific methodology by which states have crafted their laws and regulations include these criteria and interpretive guidance for implementation. That will become the topic of our next conversation as I begin to examine Marlene and David’s experience in relationship to the locations in which they live. As we will learn, they are each having very different experiences.

This Federation of State Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain is located at this link-

Well written. Glad I stumbled upon this page. It has tons of guidelines about chronic pain issues and the implementaion of right regulation of medical uses in order to stop substance abuse. Thanks for sending out this chronic pain awareness and the state regulation policy. It has useful information to bring to people’s attention.

Thankyou Dr. Lewis for your comments here. As a Chronic pain sufferer for more than 20 years and taking opioids for that pain, I know all too well what you are saying.My current VA doctor is retireing at the end of this month, (Sept.). I am SCARED TO DEATH thinking what doctor the VA will give me. They are cutting us vets. off COLD TURKEY, in some cases. Mainly due to the fact that there doctors are not trained in Tapering. But it seems to me you are Preaching To the Choir here. Don’t take me wrong, we all need to know that there are doctors that understand our problems. But, can you tell me what you are doing to round up like minded doctors and demanding that our govt. STOP THIS NONSENCE!! Would you be willing to testify in court during a law suit against a doctor that refused to treat a patient with Intractable Pain?? Would you testify that said doctor was Harming the patient?? I am just curious. I feel that legal measures are going to be the ONLY remedy we have to change the current thinking. “FIRST DO NO HARM”. #1 in the Hypocratic Oath that EVERY doctor must adhere to. When a doctor refuses to help a patient with pain, that is Malpractice. In My Humble Opinion. Thank you for all you do. Would you like to take on a new patient?? I been on my meds for over 20 years and take as prescribed, do UDS, counts and all.

Hi Kristine –
The language we use is important. Across policy and guidance documents it is inconsistently applied and that leads to variation in available services. The term intractable pain is not used here because the Federation of state medical boards (FSMB) does not incorporate the term into their guidance document to state medical boards. It is my intention to illustrate how this can lead to errors of policy development and regulation.

Thank you for caring and doing all the work in this field that many of us are to sick to do. I have Intractable Pain and was wondering why that was not listed in your list of definitions of pain. My spine is collapsing form Osteoporosis, my fusions fail from soft bones, my bone pain is intense , and I have severe Fibromyalgia. I am highly educated never have done drugs and was refused at a pain clinic for Morhphine since I took 5 more pills than prescribed. This was 2 weeks post op and I had rods protruding from my spine almost breaking my skin. At this point I tried to committ suicide and was put in a psych ward where I had the knowledge to recieve ETC because of my psychology background. The treatments were scary and horrible but brought back my will to live and I weighed only 128lbs at 6 ft tall, It was obviously pain was killing me. All I did was curl up in a ball and pray to die. No one cared. After I left the Psychiatric ward I found a lovely pain clinic that saved my life. I just recieved my pain pump last week and have positive hopes that this will help my quality of life. To watch someone someone suffer because of fear of addiction is not only inhumane it is a violation of our civil rights. Please I beg someone out there with money,power, and a heart to help people like me because we are many and have a lot to offer this world and could be your mother, father, son, or daughter. I was healthy happy and wanted to live but when the pain got so bad I couldn’t teahc anymore I was devastated. the kind of suffering I was experiencing was not living and I would of committed suicide without help. Why are there not better medications than over the counters for pain. Tramamdol, Antidepressants, seizure meds, muscle (to many to list, are woefully lacking in helping with pain yet are given along with a good pscychologist, and pt. Well what happens when that doesn’t work for most of us. Then what?

Doctors wont prescribe high dose opioids. It doesnt matter that youve taken them for ten years. They are all doing the cdc GUIDELINES for fear of jail. We are just the population that is no longer needed. Our pain will drive us to suicide and heroin. We hsve been given a death sentence. But the junkies could get treatment. If youre disabled youre a waste to the american population. Im one of them.im ready to commit illegal acts. Why not im gonna be dead anyway.

@Jody Bernstein, this sample of two is not mean to exemplify a statistical narrative. I don’t believe either of these individuals would characterize their personal experience as ‘fluffy’ or invalid. Marlene lost her legs due to continuous mischaracterization and medical harm. David is at risk of suicide due to medical harm and undertreatment. He expresses it clearly.
These examples will be used to illustrate the journey of two persons with intractable pain as they navigate their systems in their own home states utilizing the very different laws and regulations in play. Stay tuned.
In order to understand why consumers are having the experience they are, we have to understand how individual regulatory differences impact the thousands of individuals who are at risk.

To who ever it concerns thank you so much. please feel free to publicly post and use this my story and grief of this horrible malady and the the Hell the now uninformed Public and some of the Media are putting us legitimate Chronic Pain Sufferers through! It is no more than local emotional Abuse ( and border line Domestic Emotional Terrorism )!on a scale with only Biblical proportions!To the Editor and Associates I have taken this opportunity to share my heartbreaking story in hopes these witch hunting Opiate ill informed skeptics will read and understand that we as Millions Of Legitimate Chronic Pain Sufferers would have no life without Medically prescribed Opiates by a physicians care and strictly monitored monthly urine and blood test. Please remember that An Opinion Before A Thorough Investigation Is The Epitome Of Ignorance! And that a little more compassion from the Medical Field and its representatives could have saved my beautiful Stepdaughters life. Let me say this! A person who has a addictive personality will abuse anything that helps them feel better. I have taken Oxycontin for 12 years , I have had 20 major surgery’s in 9 years. I have so much physical pain I can not even get out of bed with out pain meds and when I run out I run out and just lay in bed praying the Lord relieve me of this horrible condition and I pray God you pain med skeptics never go through what I go through everyday of my life when the only thing you have to do is threaten what help I get, Shame on them! There will always be drug abuse and as the so called war on drugs has failed all this will! All you do is stoke and aid the drug pushers business to knew heights in the Black Market of Heroin while trying to deprive folks as me to this horrible movement! My Stepdaughter committed suicide 4 years ago because of being treated like a drug addict by her family and doctors when all along she suffered from Lupus and Fibromyalgia which I believe was brought on by a deadly car crash at 18 , she told me between that which I was being put through and what they were putting her through she was not going to be able to live her life in such a hell brought on by people like the Biased Uniformed Skeptics that are on a witch hunt to out law Opiates and pain meds that give us some sort of a life . As a retired Police officer and worked indirectly close to the DEA, you people do not have a clue how thrilled you are making the illegal opiate trade and think of my Late Stepdaughter as you continue on with this 2017 Version of the ( 1940s Propaganda Film named REEFER MADNESS )movement to outlaw opiates! Just like the slaughter of children at Sandy Hook if there would have just been gun laws , my God they were Gun Laws , the guns that murdered all those 20 children were all registered and owned by a school teacher! You fight Drug Addiction in Elementary education by teaching all children the dangers of Booze and Tobacco which if these witch hunters want for us to know the real truth but they do not. I miss my Stepdaughter so much and some of us will continue on the fight to protect our right to feel better and function without fear of these witch hunters trying to convince us to commit suicide . And they are trying to do exactly THAT and are now being successful in this under the table practice of Human Genocide!
The under line real truth it seems THESE witch hunters would rather us Chronic Pain sufferers commit suicide are and DRINK all the BOOZE we can drink! The Federals legalized it ( ALCOHOL) knowing its a more deadly drug than Strychnine. And just because the DEA has miserably failed with their witch hunt type movement on drugs why do they continuous fully deprive us sick people of our Constitutional Rights to be Happy in that pursuit of with Professional Physicians to take meds that give us relief of this horrible malady of Chronic Pain ! May God have mercy on their miserable souls they that seek to destroy us Chronic Pain Sufferers only and little hope of temporary relief of this horrible sickness.

Giving a. Example of two people’s experie ce with opiates is a sample of two and as such is meaningless from a statistical perspective. It is not valid or reliable, rather it is fluff. Here is the issue broken down to simple terms
ECONOMICS OF THE OPIOD EPIDEMIC

The truth is that the CDC and the DEA are responsible for the opioid epidemic, period! How? Well, my experience with this product line spans on and off for some 33 years. In the beginning, any amount of pain was treated by most doctors with some kind of narcotic.. nobody questioned it, nobody died. However, as demand for these products, and make no mistake, that is what they are, grew; more and more qualified pill doctors popped up to satisfy increased demand. I’m thinking early 80’s to about 2010. Qualified suppliers increased to meet demand, even tho many people didn’t need them, an opportunity was created, let’s say a market with an increased demand. This is microeconomic theory at work. Makes perfect sense. Fast forward to today….

The CDC and DEA have waged war on pharmaceuticals with a narcotic, or opiate, base. They have now gone so far as to say pharm companies will be manufacturing less of these products in 2018. They have severely cut the amount that can be prescribed to anyone, regardless of pain level. Economically speaking, supply has been cut, yet demand remains the same.

This has created a shift in demand whereby those who used to get these products in the legal market no longer can, so a secondary demand is created causing a shift from demand of these products in legal markets to creating a demand in illegal markets. This demand is satisfied by herbal products ordered off the internet, coming from countries and being unregulated, contain deadly agents. This is what is creating the increase in deaths from so called opioids. Additionally there are illegal suppliers in this country who make labs out of their basements and make deadly copycat products which cannot be differentiated, by sight, from the legal pill products. The result is people die.

The bottom line is had the CDC and DEA not waged war on legal suppliers, the secondary market, the illegal one in which people are dying, would NEVER HAVE FORMED. There would have been no demand.

Now, I’m not saying g opiates are good, I hate them, yet there are days I could not get thru without a little chemical help. Most of the pain patients with whom I regularly I teract hate them also, yet we have few AFFORDABLE alternatives. Yet we are being cut off completely in some cases, which to those who don’t have the money for massage, or acupuncture, reiki, cupping, etc. Can easily die. IT IS A FACT ILLEGAL DEMAND WAS AND IS CREATED BY GOVERNMENT ORGANIZATIONS.

Ok ok, reduce supply, but for heaven’s s sake realize the illegal demand created by your actions, and start covering alternative pain reduction methods in the Medicare and Medicaid markets where most of us exist !!! To cut supply and not somehow accommodate the illegal demand you WILL ALWAYS CREATE just shows stupidity on the part of the government agencies involved!!! So, thank you CDC and DEA for killing our citizens. How does this differ from terrorism? It is in effect domestic terrorism, period!!!!

Dr. Lewis, it is surely wonderful to hear from you again.
Thank you for this post and for the hard work that you have put into this research and for putting it all together.
I look forward to more from you as this month goes on.
It is my hope that your work ends up in the proper hands, if not already.
I am well aware of the intense work you have done on our behalf, thus far, and imagine that there is so much more that I am unaware of.
You always remain an incredibly hard worker.
I extend my Gratitude to you,
Maureen
@Dr. Gephart, God bless you for your chosen career and all that you endure with your illness. You are a special person for sure. Keep strong.

Thank you Dr. Terri Lewis for the article, as one living in chronic pain for the past 17 years due to failed low spine fusion with hardware implanted, among some other spine injuries since 2000, I don’t know what without opioid pain medication, I just don’t know.

Thanks Robert Gephart – it’s like herding cats to keep up with these changes and figure out how folks will be affected across the various states. Your kind words are appreciated and I look forward to your continued feedback.

Rachel – what you have noticed is that there is a missing definition in a guidance document issued to the states. You are correct. Intractable pain is associated with pathology but is not recognized in FSMB sguidance – and that leaves a pretty large hole in regulation design and development.

We’ll be getting to the impact of this omission in future discussions. One has to ask how one can guide the regulation of pain through an addiction or acute pain model ? How have we failed to recognize the impact of this faulty assumption?

Many thanks to you for your excellent work Dr Lewis. I am a psychologist emeritus and have taught at the college and university level as well as maintained a private practice for over thirty years. My teaching assignments have always included course work on drugs and addiction, so I am not naive about the effects opiates can have on users.
I have FSHD, a chronic and progressive form of muscular dystrophy. I began using opiates almost 10 years ago when I developed an allergic reaction to NASIDS. Given what I knew about opiates I was extremely apprehensive to begin taking them. I knew my father, from whom I inherited FSHD, took Talwin (pentazocine) for many years before he died and that it was helpful to him. So I started with a prescription of opiates. These medications have allowed me to live my life in a fairly normal fashion and I am thankful to have them. Clearly the worst part of using them for me is the stigma and all the rest of the social things that go with their use.
It is my hope that the atmosphere surrounding the use of these drugs will improve over time as the kind of work Terri Lewis, PhD is doing becomes better known. Kudos to you Dr Lewis.